Quality Assurance Senior Specialist
1 month ago
Job Description:
The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene.
Monday-Friday shift
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
Key Leadership Skills
Cross- functional collaborator
Results Driver
Key Knowledge/ Skills and Competencies
Strong leadership skills with the ability to thrive in a high throughput environment
Collaboration / TeamworkAbility to independently lead cross-functional teams and represent the Quality unit
CommunicationAbility to communicate effectively across all organizational levels
Critical Thinking / Problem SolvingAbility to evaluate quality matters and make decisions utilizing risk-based approach
Attention to detail
Knowledge in the following areas:
Expert knowledge of GMP requirements governing oral drug products manufacturing practices
Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience providing QA operational support of GMP manufacturing
KEY RESPONSIBILITIES:
As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
Responsible for batch disposition activities.
Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Responsible for review and approval of COAs, and product release
Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
Develop and deliver technical training programs
Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed
Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
Provides experienced technical advice for fill finish related program decisions
Provides project support involving technical transfers, engineering projects and similar activities
Participate in compliance walkthroughs and help drive the closure of any observations
Responsible for identifying risks and communicating gaps for GMP process/systems
Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
Participate in inspection readiness and support activities
Participate in process improvement initiatives (as necessary).
Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner
Experience on product complaints investigations and recalls
REQUIRED EDUCATION AND EXPERIENCE:
Demonstrated success by independently leading cross-functional teams
Experience providing QA support and oversight of GMP manufacturing operation including batch release
Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:Cell and gene therapy cGMP's and associated CMC regulatory considerations
Aseptic processing
Experience successfully leading event investigations, Root Cause Analysis and CAPA
Experience with network-based applications such as Oracle, TrackWise
Master's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.
Pay Range:
$60-$65/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex").
The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting.
The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your RESUME/Resume, email address or phone number, with Vertex.
(collectively, "Atrium Alerts"). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
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